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Practicing Full Scope Primary Care Optometry: Is This Still Fun??
Pamela A. Lowe, O.D., F.A.A.ODiplomate, American Board of Optometry
Professional Eye Care Center, Inc.Chicago/Niles, Illinois
Disclosures
Disclosures
Speaker’s Bureau for:
-Alcon-Diopsys-Heidelberg-Maculogix-Optos-Reichert-Zeavision
Know Your Lecturer
-Loyola University of Chicago, 1984
-Illinois College of Optometry, 1988
-Associate optometrist private practice 1988-1992
-Solo practitioner after purchase of Chicago practice 1992
-Professional Eye Care Center, Inc. is a full-scope, primary care setting-moved location in 2007 from 1900 sq. foot space to 5400 sq. foot facility, currently employ one full-time associate doctor, eight full-time employees, and four part-time staff, part-time marketing director
Lecture Objectives• Look at trends that affect the profession
• Look at best practices for practicing optometry into the future
• Look at practical applications for implementing technologies
• Practicing good optometry is best for patients health and great for practice health!
Optometric Oath
• “I will advise my patients fully and honestly of all which may serve to restore, maintain or enhance their vision and general health.
• I will strive continuously to broaden my knowledge and skills so that my patients may benefit from all new and efficacious means to enhance the care of human vision.”
2
The Why? Trends in Optometry
• Profession roots based on optics
• Practice of optometry grew to behavioral/ functional vision incorporating therapy other than spectacles
• Optometry scope of medical practice grows from diagnostic only to therapeutic
• We owe it to our profession, and, most importantly our patients, to advance with technology
Trends in Optometry
• With scope of practice expansion and market place trends making the “retail” side of optometry a “commodity” our practice models must change and adapt
• Practice growth will be based on advanced technologies and converting to a medical model
Is this still fun??
Super Buzz Kill!! IT HAPPENNED!!
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Is it fun?? Let’s take a different view!
AMD-The Bohemoth!!• Prevalence of AMD
– 9.2 million Americans– 7 out of every 100 adults over 40 years old– 1 out of every 8 adults over 60 years old– 1 out of every 3 adults over 75 years old
• Prevalence of diabetic retinopathy– 4.9 million Americans– 3 out of every 100 adults over 40 years old
• Prevalence of glaucoma– 2.7 million Americans– 2 out of every 100 adults over 40 years old
Klein et al. (2011) Arch Ophthalmology 129:75Eye Disease Prevalence Group (2004) Arch Ophthalmology 122: 532Eye Disease Prevalence Group (2004) Arch Ophthalmology 122:5522010 United States Census
June 16, 1922-February 19, 2012
AMD LANDSCAPE
4
Large Unmet Need
Klein R, et al. Arch Ophthalmology. 2011;129(1):75-80. Eye Disease Prevalence Research Group. Arch Ophthalmology. 2004;122(4):532-538. Eye Disease Prevalence Research Group. Arch Ophthalmology. 2004;122(4):552-563. 2010 United States Census
Prevalence of AMD• 9.2 million Americans• 7 out of every 100 adults over 40 years old• 1 out of every 8 adults over 60 years old• 1 out of every 3 adults over 75 years old
Prevalence of diabetic retinopathy• 4.9 million Americans• 3 out of every 100 adults over 40 years old
Prevalence of glaucoma• 2.7 million Americans• 2 out of every 100 adults over 40 years old
Gap in Diagnosis of AMD
Cervantes-Castañeda RA, et al. Eye (Lond). 2008;22(6):777-781.
Olsen TW, et al. Ophthalmology. 2004;111(2):250-255.
Early/Dry AMD Late/Wet AMDNormal
• Up to 78% of AMD patients have irreversible vision loss at first diagnosis, including 37% who are legally blind in at least one eye
• Early AMD is not adequately detected by current methods
Call for Early Diagnosis
David Brown, MD, FACSRetina Consultants of Houston
“Many AMD patients are arriving at our practice with unnecessary vision loss. Ideally these patients would see their primary eye physician and be diagnosed earlier.”
Preventing Unnecessary Vision Loss
VEGF, vascular endothelial growth factor.
Age-Related Eye Disease Study Research Group. Arch Ophthalmol. 2001;119(10):1417-1436. Age-Related Eye Disease Study 2 Research Group. JAMA. 2013;309(19):2005-2015. Boyer DS, et al. Ophthalmology. 2007;114:246-245. Loewenstein A. Retina. 2007;27:873-878.
Available Interventions Prior to Advanced AMD• AREDS2 nutritional supplements lower risk of progression by
25%
• Behavior modification also lowers risk of progression
Available Interventions for Choroidal Neovascularization (CNV)
• Prompt anti-VEGF therapy can save up to 5 lines of visual acuity
• Dramatic loss can occur in as little as 8 weeks
(off label)
ROLE OF DARK ADAPTATION IN AMD
AMD Pathogenesis
Curcio CA, Johnson M. Structure, function, and pathology of Bruch’s membrane. In: Ryan SJ, et al, eds. Retina, Vol 1, Part 2: Basic Science and Translation to Therapy. 5th ed. London: Elsevier; 2013:466–481.
Cholesterol accumulation leads to panmacular
deposits (BlinD and BlamD)
Peaks in these deposits eventually become clinically
visible drusen
These extracellular cholesterol deposits affect
photoreceptor health, causing inflammation
and predisposing to CNV
In addition, they impair normal transport, including
that of vitamin A, across Bruch’s membrane
RPE
Bruch’s Membrane
Photoreceptors
Sclera
Drusen
5
AMD Pathogenesis
Curcio CA, Johnson M. Structure, function, and pathology of Bruch’s membrane. In: Ryan SJ, et al, eds. Retina, Vol 1, Part 2: Basic Science and Translation to Therapy. 5th ed. London: Elsevier; 2013:466–481.
Drusen
RPE
Bruch’s Membrane
Photoreceptors
Sclera
In effect, AMD causes a localized deficiency of vitamin A, and dark
adaptation is the best test to measure this change
Dark Adaptation
Dark adaptation is the process of adjusting from day vision to night vision
Easy-to-measure aspect of night vision
First Symptom of AMD
Night vision impacted in early disease: 20+ studies
AMD patients often give up driving at night
Night vision is impaired before day vision
Difficult to determine whether night vision is impaired because of AMD or aging
ADAPTDX® OVERVIEW
First dark adaptometer for rapid, routine clinical use
Simple, objective tool to measure dark adaptation as earliest functional correlate of macular dystrophies
Two clinical protocols• ≤6.5-minute rapid test (for
quick assessment)• ≤20-minute extended test (for
benchmarking)
How AdaptDx® Works
Simple, noninvasive test performed in-office by ophthalmic technician
While continuously focusing on fixation light, patient is exposed to a mild bleaching flash and asked to indicate when a progressively dimmer stimulus light appears (randomly timed)
stimulus lightfixation light
trial lensholder
forehead rest
chin rest
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How AdaptDx® Works
fixation light
bleach area
stimulus light
Dark Adaptation
Jackson GR, et al. Vision Res. 1999;39(23):3975-3982.
Leibrock CS, et al. Eye (Lond). 1998;12(pt 3b):511-520.
Dark Adaptation Is a Major Impairment in AMD
Rapid Test: ≤6.5 minutes Extended Test: ≤20 minutes
AMD
Normal
AdaptDx® Diagnostic Study
Jackson GR, et al. Invest Ophthalmol Vis Sci. 2014;55(3):1427-1431.
Multisite study
Sample consisted of 127 AMD patients and 21 normal adults
Clinical diagnosis confirmed by retina specialist grading fundus photographs
AdaptDx® Diagnostic Study Results
• Patients classified as having AMD if dark adaptation >6.5 minutes
• High sensitivity: correctly identified 90.6% of confirmed AMD cases
• High specificity: correctly identified 90.5% of confirmed normal cases
• High overall accuracy of 90.6%
• AMD cases exhibit no rod recovery of dark adaptation
• AdaptDx rapid test – ideal for routine clinical use
Jackson GR, et al. Invest Ophthalmol Vis Sci. 2014;55(3):1427-1431.
AMD
Normal
How Good Is 90%?
Seddon JM, et al. Ophthalmology. 2006;113:260-266. Tikellis G, et al. Clin Experiment Ophthalmol. 2000;28:367-372.Ervin A-M, et al. Screening for Glaucoma: Comparative Effectiveness. Rockville, MD: Agency for Healthcare Research and Quality; 2012. Comparative Effectiveness Review Number 59. http://www.ncbi.nlm.nih.gov/books/NBK95371/pdf/Bookshelf_NBK95371.pdf. Accessed June 6, 2012.
Visual field testing to detect glaucoma is 83% sensitive and 95% specific
Retina specialists using slit lamps to detect AMD are 82% sensitive and 91% specific
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Clinically Validated at Leading Institutions Example of an AdaptDx® Report
Eye tested and characteristics
AdaptDx dark adaptation curves
Rod intercept time and clinician assessment (>6.5 minutes consistent with AMD)
Patient name, DOB, and ID number
• 75 Year old female• 20/25 OU• No AMD family Hx• Nonsmoker• Large soft drusen
• 75 Year old female• 20/25 OU• No AMD family Hx• Nonsmoker• Large soft drusen• OCT findings of
drusen
• 75 Year old female• 20/25 OU• No AMD family Hx• Nonsmoker• Large soft drusen• OCT findings of
drusen• Abnormal dark
adaptation
Case 1: AMD
Courtesy of Amanda Legge, OD, Wyomissing Optometric Center
Case 2: Subclinical AMD
• 65 Year old female• 20/20 OU• No AMD family Hx• Nonsmoker• Subtle drusen
• 65 Year old female• 20/20 OU• No AMD family Hx• Nonsmoker• Subtle drusen• Unremarkable OCT
• 65 Year old female• 20/20 OU• No AMD family Hx• Nonsmoker• Subtle drusen• Unremarkable OCT• Abnormal dark
adaptation
Courtesy of Amanda Legge, OD, Wyomissing Optometric Center
Dark Adaptation Is NOT a Risk Factor for AMD
Impaired dark adaptation is NOT a risk factor. It is the earliest manifestation of disease.
Genetic testing and macular pigment density (MPOD) can indicate a heightened risk for developing
AMD, but neither indicates the actual presence of disease.
AdaptDx® Advantages
No prior adaptation required
Low patient burden
Short test duration
Automated analysis
Objective output (rod intercept)
CPT 92284 ($63 avg)
FDA 510K cleared (K100954)
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WHAT DOES A POSITIVE ADAPTDX® TEST MEAN?
Case Example With Positive AdaptDx® Report
You have implemented AdaptDx in your practice
and test a patient who has impaired dark adaptation.
NOW WHAT?
What Does a Positive AdaptDx® Report Mean?
AMD Patient SubclinicalAMD Patient
Look at the patient’s other characteristics with imaging tools
1. Are there drusen?2. Are there pigmentary changes including geographic atrophy?3. Is there evidence of choroidal neovascularization?
Other characteristics
of AMD
No other characteristics
of AMD
AMD Patient – Treatment Protocol
American Optometric Association. “Care of the patient with age-related macular degeneration.” (2004)
Examination: annual, semi-annual, or more frequent dilated exams (depending on AMD severity)
Testing: BCVA, biomicroscopy, macular function assessment (such as dark adaptation), imaging (fundus photos or other), PHP (preferential hyperacuity perimetry), pERG
Management: consider anti-oxidant supplementation & UV protection, provide counseling on behavior, Amslergrid, PHP (preferential hyperacuity perimetry), pERG
Referral: immediate consultation with retina specialist upon clinical signs or symptoms of choroidal neovascularization
Subclinical AMD Patient – Treatment Protocol
Examination: monitor as appropriate depending on risk factors (age, family history, smoking, weight, genetics)
Testing: BCVA, biomicroscopy, macular function assessment (such as dark adaptation), imaging (fundus photos, OCT), pERG
Management: consider nutraceutical supplementation & UV protection, provide counseling on behavior (diet/exercise)
Co-Manage as Appropriate
Optometrist or General
Ophthalmologist
RetinaSpecialist
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PRACTICE INTEGRATION MODELS
50
Clinical Utilization Case #1
Multispecialty optometry practice
Dedicated testing visit
Rapid Test to discriminate night vision impairment due to cataract
vs retinal pathology
• Extended Test on both eyes to benchmark dark adaptation time that can be tracked from visit to visit
• Determine patient management program based on results of testing (eg, quarterly, semi‐annual, or annual appointment schedule)
Insurance reimbursement only• Primarily tests known AMD patients to benchmark impairment• Tests night vision complaints to differentiate cataract from AMD
AMD benchmark testingCataract vs AMD
ROI: Conservative use based on known pathologies provides positive investment return with less than 1 test per day
51
Clinical Utilization Case #2
Two optometrists, comprehensive practice
1 hour follow‐on appointment scheduled
Patients can be asked again at next visit
Previously undiagnosed AMD is discovered in 25% of
these patients
Patient‐pay initial testing at future dedicated visit with follow‐on insurance visits• $65 dark adaptation test offered to patients meeting risk profile (over 60, family history of AMD, smoker, overweight, poor night vision, etc)
90% elect to pay for testing10% decline testing
ROI: Patients that used to be worth $80 every 18 months are now worth $660 every year. Nutraceutical sales increased 65% year over year.
52
Clinical Utilization Cast #3
High‐volume refractive surgery/cataract practice; multiple ODs/MDs
Testing performed at current visit using Rapid Test of one eye to get “yes/no” determination
Patients can be asked again at next visit
40% of patients are impaired (test positive)
60% of patients are unimpaired
Patient‐pay initial testing during current visit with follow‐on insurance visits• $65 dark adaptation test offered to patients meeting risk profile (over 50, family history of AMD, smoker, overweight, poor night vision, etc)
60% elect to pay for testing40% decline testing
ROI: Practice is generating over $100,000 per year of new revenue from AdaptDx® (including ancillary testing such as OCT and nutraceutical sales triggered by AdaptDx findings) vs $34,700 AdaptDx list price
OCT, optical coherence tomography.
Clinical Utilization- My Practice
Two optometrists, comprehensive practice
Dedicated testing visit
Rapid Test to discriminate night vision
impairment due to cataract vs
retinal pathology
• Extended Test on both eyes to benchmark dark adaptation time that can be tracked from visit to visit
• Determine patient management program based on results of testing (eg, quarterly, semi-annual, or annual appointment schedule)
Insurance reimbursement or patient pay if HMO/uninsured• Primarily tests known AMD patients to benchmark
impairment• Tests symptomatic to differentiate early AMD from all other
conditions
AMD benchmark testingOther conditions vs sub-clinical AMD
Dedicated testing visit
How AMD Diagnosis Changes Your Practice
Good for your patients• If AMD is detected early, there are effective interventions that can
preserve vision and improve quality of life
Good for your practice• An AMD patient is estimated to add from $350 to $600 per year to
practice revenue
Rumpakis, J. Optometric Management. Jul.1, 2013.Rumpakis, J. “The AMD Center of Excellence.” AOA Annual Meeting 2014.
10
Proactive Testing Model
Testing with AdaptDx® Rapid Test
based on risk factors
Discovery of previously undetected early and
subclinical AMD
Benchmark characterization- AdaptDx®
Extended Test
- imaging
Increased exam frequency (as appropriate) with follow-up testing:- AdaptDx®
Extended Test- Imaging, etc
Recommend or sell
nutraceuticals(as appropriate)
Patient self-pay
or
ICD-9 368.60 - night blindness, unspecified
Early AMD:ICD-9 362.51 - dry AMD
or
Subclinical ADM:ICD-9 368.63 -abnormal dark adaption
Initial Assessment Subsequent Management
Early AMD:ICD-9 362.51 - dry AMD
or
Subclinical AMD:ICD-9 368.63 -abnormal dark adaption
Return on Investment Calculator
PracticeVolume
(per week)
Total ROI
(annual)
25 $33,009
50 $66,018
75 $99,027
100 $132,036
Enter number of doctors in practice who will use AdaptDx: 1
Enter practice volume (patients per doctor per week): 50
During a typical week, initial testing will be conducted on 13 patients which will
find 1.6 new AMD patients.
Total new yearly revenue to the practice is $66,018.
Yearly additional revenue from initial AdaptDx testing is $43,940.
Yearly additional revenue from semi annual visits is $8,896. Yearly additional revenue from supplement sales is $13,182.
Total yearly revenue from each AMD patient is $727 not including retail vision.
KEY TAKEAWAYS
Key Takeaways
AMD is a highly prevalent condition that causes preventable vision loss
Proactive detection and management of early and subclinical AMD can transform a practice and ensure better patient outcomes
AdaptDx® can help preserve vision and improve quality of life
Cases: EG
• 76yo WM with Hx of macular hole/epiretinal membrane
• 20/40 OD, 20/20 OS BCVA
• Sx’s of decreasing vision at night
• Active bowler; needs to maintain sharp VA
• OCT stable OD, negative OS
Case EG
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Cases: JG
• 67yo WM with Hx of macular drusen
• 20/15 BCVA OU
• Monitored q3-6mos pERG & PHP with no changes over 3 years
• Taking Eyepromise Restore 2 tabs PO QD
• Do I need to monitor so often????
Case JG
Cases: FG
• 63yo WF with Hx of peripheral drusen
• 20/30+ BCVA OU from mild cataracts
• Sx’s of decreasing visual comfort over time
• Considering cataract consult
• OCT negative OU
Case FG
Cases: WK
• 71yo WM with Hx of peripheral drusen
• 20/20 BCVA OU
• Family Hx of AMD with Mother and Sister
• HTN med only
• Genetic testing shows MR1, 75% Genetic Lifetime Risk, AREDS without zinc recommendation
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Cases: PS
• 67yo male Pacific Islander with Hx of macular drusen
• Negative family Hx of AMD
• Lipitor med only for Hypercholesterolemia
• pERG function mild decrease magnitude OD, normal sinusoidal curve OU
• No signs of choroidal neovascularization on OCT OU
• BCVA down-2014 noting cataracts 20/60 OD, 20/40 OS
• Successful cataract extraction OU 20/20 OD, 20/25 OS
• Genetic testing shows MR2, 34%-Genetic Lifetime Risk, AREDS without zinc recommendation
Are we having fun yet?? Medical Optometry-Anterior
• Lashes-Hypotrichosis
Medical Optometry-Anterior
• Lashes-what women really want
Medical Optometry-Lashes
• Latisse has been standard since 2009
• Rx only
• Potential side effects, IOP lowering, permanent iris pigmentation, permanent lid pigmentation
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Medical Optometry-Lashes
• New cosmestic Tx; no pharmacy Rx needed
• Zoria distrubuted through
OcuSoft
• No side effects
BOOST Lash intensifying serum
• Lili Fan, M.D. is visionary scientist and entrepreneur whose list of achievements include:
• Ophthalmologist
• Patents for polymeric and oligomeric biosurfactants
• President and Founder of Luksus® Skin Biomedical
• Founding Director of Owen Botanical Organics, Inc.
How it works
• Zoria™ Boost Lash Intensifying Serum utilizes patented polypeptide technology to naturally enhance and support each of the three phases of the eyelash growth cycle. The result: dramatically longer, fuller and darker looking eyelashes.
• These three phases are known as:
1. Anagen (active growth)
2. Catagen (transition)
3. Telogen (resting)
Anagen
CatagenTelogen
Eyelash GROWTH cycle
1. The Anagen (active growth) Phase - lasts between 30 -45 days. In this phase, the patented polypeptide technology in Zoria™ Boost stimulates keratin genes and hair follicles to support natural eyelash growth.
2. The Catagen (transition) Phase - lasts 2 -3 weeks. During this phase, the eyelash stops growing once it reaches its maximum length and volume. Zoria™ Boost strengthens, repairs and protects the eyelash in this transition phase.
3. The Telogen (resting) Phase - lasts approximately 100 days (16-36 weeks) before the eyelash eventually falls out. Each individual eyelash undergoes each phase at different times. On average, complete replacement of an eyelash occurs between 4-8 weeks. Zoria™ Boost not only nourishes and conditions eyelashes to prepare for the next growth cycle, it also prolongs the Telogenphase creating the appearance of longer, fuller lashes.
Clinical study – in vivo data i
• Thicker, Darker and Longer Looking Eyelashes
• Panel: 15 subjects, 24-82 years old
• Test Product: A conditioner with patented lipopeptide
• Measurement: EyeTest lash measurement by SigmaScan software
Clinical study – in vivo data i
• After two weeks of use
Before After
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Clinical study – in vivo data ii
• Thicker, Darker and Longer Looking Eyelashes
• Panel: 4 subjects• Test product: Eyeliner serum applied on the root of the
eyelashes once a day at night• Measurements: 2, 4 and 6 weeks – Canon 5 – DMII
calibrated with micrometers to accurately calculate distal length and width. Cameras mounted on permanently fixed tripods shooting directionally above the anterior eyelids. Patients are inclined on a physician lab chair to maintain subject stability. Software programs are a composite of commercially available Canfield, Hasselblad and proprietary programs to represent eyelash density analysis.
Clinical study – in vivo data ii
• After 2-6 weeks of use
Day 0 Day 14 Day 28
Day 42
Availability/Cost
• Zoria™ Boost Lash Intensifying Serum is exclusively available through eye care professionals and now on-line…Amazon $100.00 OcuSoft $130.00
• Cost per tube: $60
• Suggested retail price: $100 - $120
• Item #720-5-01
Key Points
• All-natural• Patented Polypeptide Technology• Cosmetic grade active ingredient whereas
Latisse® is a prescription drug• Cosmetically safe – no allergic response,
iris or skin discoloration• Lasts twice as long as Latisse® for the
same price (Latisse® = $120 for 3 mL fill and Zoria™ = 6 mL fill)
Marketing Materials
8.5” x 11” Detail Sheet 19” x 27” Poster with Purchase
Interview with Dr. Marguerite McDonald
http://www.yohttp://www.youtube.com/watch?v=PI-ACQvEGBA&feature=youtu.beutube.com/watch?v=PI-ACQvEGBA&feature=youtu.be
15
Other Lash Product
• Zoria™ Mascara For Sensitive Eyes
– Creates beautifully defined, natural looking eyelashes without any clumps or flakes
– Safe for sensitive eyes and contact lens wearers
– Hypoallergenic
– Ophthalmologist Tested
– Cost per 0.25 oz. tube = $12.50
– Suggested retail price = $24.99
Other Lash Products
• Zoria™ Mascara with lash boost
– Creates beautifully defined, natural looking eyelashes with boostener added
– Safe for sensitive eyes and contact lens wearers
– Hypoallergenic
– Ophthalmologist Tested
– Cost per 0.25 oz. tube = $ 24.50
– Suggested retail price = $ 48.95
Medical Optometry-Lids Medical Optometry-Lids
• Blepharitis; Anterior/Posterior
• Demodex Mites (Underdiagnosed)
• Dermatochalasis
• All conditions lead to dryness (Tears need lids!)
What is Blepharitis?
• Blepharitis is an inflammation of the eyelids causing red, irritated, eyelids and the formation of dandruff-like scales on the eyelashes.
• Symptoms include itching, burning and foreign body sensation.
• Reoccurrence is common and may lead to Trichiasis.
Two Types of Blepharitis• Anterior Blepharitis: Occurs at the outside front edge of
the eyelid where the eyelashes are attached.
• Posterior Blepharitis: Affects the inner edge of the eyelid that comes in contact with the eyeball.
16
What Causes Blepharitis?
• Allergic
• Seborrheic (Dandruff)
• Bacterial (Staph Infection)
• Demodex Mites (under diagnosed)
• Irregular Oil Production by the Glands
• Other Skin Conditions Such as Acne Rosacea and Scalp Dandruff
What Treats Blepharitis?
• Blepharitis cannot be cured but it can be treated and controlled through proper eyelid hygiene
• Gentle scrubbing of the eyes with a mixture of water and baby shampoo or an over-the-counter lid cleansing product – OCuSOFT® Lid Scrub®
is often recommended
• Warm compresses can be applied to loosen the crusts
• In cases involving bacterial infection, an antibiotic may also be prescribed.
Blepharitis Treatment Options
• Chronic condition needs to be monitored depending on it’s severity
• Those on oral meds need to be monitored every 3-6 mos.
• Patients need to be well educated on importance of maintaining this chronic condition
Newer Treatment Options
• Deep cleaning for lids
• In-office procedure
• Topical anesthetic
• Lid cleanser
• Saline Rinse
BlephEx Tx• Topical anesthetic
• Lid cleanser
• Saline Rinse
• Office visit + Tx fee ($150 sug.)
• One tip/margin (4 tips $16.00)
BlephEx Tx
• https://www.youtube.com/watch?v=rnVYXqk8D28
17
BlephEx Tx Protocol
• Chronic/Moderate to Severe Blepharitis
• Demodex Infestation (Tea tree oil)
• Proper patient at home Tx (Lid Scrubs)
• Follow up in 2-3 weeks for efficacy
• Re-treatment if needed or patient non-compliance
Newest Lid Scrub
• phytosphingosine 0.2%
• a water-binding agent that mimics the natural lipid layer of the outer epidermis
• anti-bacterial and anti-inflammatory properties as well as aid in wound-healing.
Severe Cases-Combo Tx
• adjunct to OCuSOFT® Lid Scrub® products in the most severe blepharitis cases.
• Solution (0.02% Hypochlorous acid)
• Gel (0.02% Hypochlorousacid)
• Combination Tx since no cleansing properties
Avenova (Neutrox-0.01% Hypochlorous acid)
• A milder form of Hypochlorous
• Daily Use
• Non-irritating to skin
• Single therapy
Demodex Mites
Demodex mites at 400x magnification: (A) D. folliculorum adult, (B) larva, and (C) D. brevis.
Life Cycle and Risk Factors• The life-span of the Demodex mite is very short, about 14 to 18 days
from the egg to the larval stage followed by five days in the adult stage.
• Because of the limited life-span of the adult mites, mating plays an important role in perpetuating Demodex infestation. For transmission of mites, direct contact is required.
• The rate of Demodex infestation increases with age, being observed in 84% of the population at age 60 and in 100% of those older than 70 years.
• Rosacea predisposes patients to blepharitis mainly by creating an environment on the skin that congests all the oil-producing glands necessary for a healthy dermis and epidermis.
• Once Demodex infestation establishes in the face, it is likely to spread and flourish in the eye, leading to blepharitis and ocular inflammation. Again, this is because the eye is generally inaccessible by daily facial hygiene.
18
Demodex Mites**Did You Know?
• Over 75% of patients over age 45 test Demodex-positive1
• Over 40% of blepharitis patients test Demodex-positive1
• 30-fold higher count of Demodex mites in patients with cylindrical dandruff (CD) than without CD2
• Strong correlation between the number of Demodex and the severity of ocular discomfort3
References: 1. Inceboz T, Yaman A, Over L, et al. Diagnois and Treatment of Demodectic Blepharitis. Turk Society for Parasitology. 2009 33(1):32-36. 2. Gao Y-Y,Di Pascuale MA,Li W,et al. High prevalence of ocular demodex in lashes with cylindrical dandruffs. Invest Ophthalmol Vis Sci. 2005;46:3089-3094. 3. Lee SH, Chun YS, Kim JH, et al. The Relationship between Demodex and Ocualr Surface Discomfort.Invest Ophthalmol Vis Sci. 2010;51:2906-2911. 4. Liu J, Sheha H, Tseng SC. Pathogenic role of Demodex mites in blepharitis. Curr Opin Allergy Clin Immunol. 2010 Oct;10(5):505-10.
Demodex Mites
How to Identify Demodex® Mites1:1. Clinical History: Blepharitis, conjunctivitis or keratitis in adult
patients or blepharoconjunctivitis or recurrent chalazia in young
patients who are refractory to conventional treatments, or when
there is madarosis or recurrent trichiasis
2. Slit-lamp Examination: Identification of CD (cylindrical dandruff) at
root of lashes
3. Microscopic Confirmation: Detection of Demodex eggs, larvae and
adult mites on epilated lashes.
. 1. Liu J, Sheha H, Tseng SC. Pathogenic role of Demodex mites in blepharitis. Curr Opin Allergy Clin Immunol. 2010 Oct;10(5):505-10.
Demodex Mites Demodex Mites
Demodex Mites
• Figure below. The clinical features of Demodex blepharitisinclude: (A) cylindrical dandruff at the root of the lashes (yellow arrow) and inflamed eyelid, (B) conjunctival inflammation, and (C) a corneal lesion (yellow arrow).
• Figure below. The clinical features of Demodex blepharitisinclude: (A) cylindrical dandruff at the root of the lashes (yellow arrow) and inflamed eyelid, (B) conjunctival inflammation, and (C) a corneal lesion (yellow arrow).1
1. Do You Know Demodex? These mites, an overlooked cause of ocular inflammation, can be the root cause of your tougher blepharitis cases. By Jingbo Liu, MD, PhD, and Scheffer C. G. Tseng, MD, PhD
Demodex Mites
• https://www.youtube.com/watch?v=sgav_kZ_Hi4&feature=youtu.be
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Demodex Mites
Treatment Goals:
• Remove adult mites and their offspring
• Help prevent re-infestation
• Alleviate patient’s symptoms
Demodex Convenience Kit
• Kit includes:
• • Demodex® Topical Solution
• • OCuSOFT® Lid Scrub® PLUS
• • Tears Again® Ointment
• • Tears Again® advanced Liposome Spray
• • BlephBrush™
Demodex Convenience Kit
Why Demodex® Convenience Kit?• First and only kit designed to help practitioners removeDemodex mites in-office with an easy 2 step process• Helps patients control re-infestation at home with dailycleansing and ongoing maintenance
Demodex Mites-Treatment
For the practitioner:
1. Cleanse eyebrows, eyelids and eyelashes using OCuSOFT® Lid Scrub® PLUS Pre-Moistened Pads. No rinsing necessary.
2. Place a small amount of Demodex® Topical Solution on the included BlephBrush™ and gently apply to the eyebrows, edge of the lower eyelid and lower eyelashes, then upper eyelid and upper eyelashes, rewetting the BlephBrush™ with more solution as needed. AVOID DIRECT CONTACT WITH THE EYE OR STINGING/BURNING MAY RESULT.
3. Wait 2 minutes and remove Demodex® Topical Solution along with softened debris from the eyebrow, eyelid and eyelashes using a fresh OCuSOFT® Lid Scrub® PLUS Pre-Moistened Pad. The smaller squared brush of the BlephBrush™ may also be useful in removing excessive debris.
4. Repeat Steps 2-4.
5. Remove any remaining Demodex® Topical Solution with OCuSOFT® Lid Scrub PLUS. Patient may also rinse face and eye areas with water if desired.
Demodex Mites-Treatment
. For the patient:
• Continue at-home hygiene regimen and help prevent mites from returning by cleansing eyebrows, eyelids and eyelashes with OCuSOFT® Lid Scrub® PLUS Pre-Moistened Pads twice daily.
• Spray Tears Again® advanced Liposome Spray onto closed eyelids throughout the day to soothe and relieve irritation. Use as needed according to package directions.
• Apply Tears Again® Eye Ointment to inner eyelids/eyelash margins at bedtime to relieve dryness and protect against moisture loss. Use according to package directions.
Demodex Mites-Treatment
. Do not use
• on unhealthy, numb, damaged, broken skin or areas with no sensation of feeling
• on eyelids that do not close
• on areas of bruising or swelling
• on children under the age of 18 or elderly patients with reduced sensation of feeling
When using this product
• check skin frequently for signs of excessive skin irritation
• do not place extra pressure or warmth over the product
• do not apply more than once in any seven (7) day period
20
Demodex Mites-Practice Management
• Initial visit diagnosed during a full exam or urgent care visit 92000 or 99000 codes
• See for f/u to initiate in office Tx; EP 4 with fee for Demodex kit (cost $30)
• See for f/u post Tx EP 3 or EP 4 with retreatment
• VERY UNDERDIAGNOSED condition-relief for many patients!!!
Demodex Mites-Treatment
. Long term therapy/maintenance:
Tea Tree Oil is the key!
Cliradex-Metaleuca Alternifolia
Cliradex-Maintenance Tx
. 4-Terpineol, an organic compound that safely and effectively cleans and soothes the skin
Naturally: antifungal
antiseptic
antibacterial
Cliradex-Maintenance Tx
.Indications: Dry eye
Rosacea
Blepharitis
Cliradex-Maintenance Tx
.Directions: 1-2x/day
1 pad/use
-apply to lids/face and
do not open eyes for at
least 1 minute after lid
contact
-tightly closed lids but
no squinting
Cliradex-Availability
www.directdermacare.com/Amazon-$42.99
or
Doctor’s office only- Biotissue (refers to OD)
www.cliradex.com
-cost to practice $24.00
-retail price $39.00
21
Blephadex
-Tea Tree/Coconut Oil
Blephadex-In Office Use
-Tea Tree/Coconut Oil
-Gentler Tx
-Easy/efficient
-BlephEx tx with
foaming cleanser
Blephadex Eyelid Wipes/Spray
-cost to practice $
-retail price $19.95-Amazon
Starting to get a groove again?
Amniotic Membrane Tx-Paradigm Shift Amniotic Membrane Tx-Attributes
• Anti-scarring
• Anti-inflammatory
• Anti-angiogenic
• Wound healing
• Thick basement membrane & an avascular stroma
• Unique biologic actions
• Transparent
• Tensile strength
22
Amniotic Membrane Tx-Indications
• Used in ocular surface disease treatment since 1940s
• In 1997 Bio-Tissue patents a cryopreservation method which preserves the biological actions
• –anti-scarring
• –anti-inflammation
• –anti-angiogenic
• –wound healing functions
• Over 200 publications support its use
Amniotic Membrane Tx-Indications
• Band Keratopathy
• Bullous Keratopathy
• Chemical Burns of the Ocular Surface
• Corneal Epithelial Defects
• Corneal Ulcer
• Keratitis (Bacterial or Viral)
• Pterygium
• Stevens-Johnson Syndrome
Amniotic Membrane Tx-Clinical Preps Amniotic Membrane Tx-Prokera
• Easy to use in office or bedside (sutureless) avoiding treatment delay & costs of surgery
• Improves Corneal Disease outcomes via the Wound Healing abilities of cryopreserved Amniotic Membrane
• New CPT Code: 65778 for in-office placement of PROKERA®
Amniotic Membrane Tx-Insertion
• Hold with blunt forceps or fingers
• The Membrane is already properly oriented within the device
• Remove PROKERA® from Inner Pouch
Amniotic Membrane Tx-Insertion
http://youtu.be/tsjqI9lIolM -
23
Amniotic Membrane Tx-AmbioDisk
• IOP Ophthalmics
• Dehydrated amniotic tissue for use with a contact lens to hold it in place
Amniotic Membrane Tx-AmbioDisk
• No special storage-room temperature
• No rinsing or special prep
Amniotic Membrane Tx-AmbioDisk
• AmbioDisk™ is a 4th generation amniotic membrane (AM) technology - a sutureless, overlay AM disk for the office-based or surgical treatment of the ocular surface.
• The 15mm AmbioDisk configuration is available in both the Ambio2™ (35 microns thick) and Ambio5
®(100+ microns thick)
technologies. Our new 9mm and 12mm diameter versions are available in the Ambio2 option only.
Amniotic Membrane Tx-AmbioDisk
• Patient laying back with lid speculum
• Place disk on with forceps
Amniotic Membrane Tx-AmbioDisk
http://youtu.be/pbU8yA6agEI
Amniotic Membrane Tx-AmbioDisk
• New method is to apply with a contact lens and NO forceps, NO speculum using a 18mm scleral Kontour soft lens
• Apply graft to contact lens first, then patient
• Easier on patient and doctor
• Less cost of goods
24
Amniotic Membrane Tx-AmbioDisk
https://www.youtube.com/watch?v=5-F7zRlOiGE
Amniotic Membrane Tx-AmbioDisk
• https://www.youtube.com/watch?v=2VEe-y6RjiA
Amniotic Membrane Tx-Moria VisiDisc
• Visidisc is another dehydrated membrane
• Available in 10, 12 and 15mm discs in thin and thick
• 5 year shelf life
• Most cost effective of all membranes
Amniotic Membrane Tx-Maintenance
• Patient is seen for clinical f/u appropriate for healing of condition
• Amniotic membrane dissolves on it’s own over course of Tx
• Any appropriate topical meds can be used just like with bandage CL Tx
• FDA approved to stay on ocular surface for up to 30 days
Amniotic Membrane Tx-Removal
• ProKera needs ring removed-easily with a forceps
• AmbioDisk and VisiDisc require removal of contact lens
Amniotic Membrane Tx-Medical Billing
• CPT 65778
• “Placement of amniotic membrane on the ocular surface for wound-healing; self-retaining”
25
Amniotic Membrane Tx-Practice Management
• Medicare approved with approximate reimbursement $1350 range
• Cost of ProKera depends on bulk bought ranges from $800-$949 (30/60/90 billing)
• Cost of AmnioDisk is $650 range
• Cost of Moria VisiDisc is $250-$420 range
• Symptomatic patients understand costs/benefits
Let’s take this party up a notch!!
THE ROLE OF NUTRITION IN COMPLETE PATIENT EYE CARE
MAXIMIZING CARE FOR THE AMD, DRY EYE AND DIABETIC AT RISK
PATIENT
PAMELA A. LOWE, OD, FAAO
DIPLOMATE, AMERICAN BOARD OF OPTOMETRY
AMD-PREVENTION/MANAGEMENTDRY EYE-MANAGEMENT
DIABETES-IDENTIFYING/MANAGEMENT
• THE NUMBERS…
• OUR RESPONSIBILITY AS PRIMARY CARE PROVIDERS
• OUR RESPONSIBILITY TO DIFFERENTIATE
• OUR DEDICATION TO PROMOTING/LEADING THE MEDICAL MODEL
• OUR RESPONSIBILITY TO DEVELOPING ACO/MD RELATIONSHIPS
• PRACTICE SUSTAINABILITY/GROWTH
THE NUMBERS
• AMD: 16 million have AMD (8 million dry AMD at risk to wet)
-5 million have Diabetic Retinopathy, 4 million have GLC
-Nearly as many at risk AMD patients and DBR and GLC patients combined
• Dry Eye: 1 in 5 patients suffer from dry eye…main reason for CL dropouts -Up to 40% of Americans affected by dry eye at some time
• DIABETES: Affects more than 8 percent of the U.S. Population, but roughly 7 million people are unaware that they have this condition, according to estimates from the CDC.
Chicago Area: 2010-1,132,582 (11.73%), $10.34 Billion in cost
2015-1,333,689 (13.52%), $12.42 Billion in cost
2020-1,655,999 (16.18%), $15.92 Billion in cost
FULL SCOPE PRIMARY CARE PROVIDERS• AMD-
IDENTIFYING THOSE AT RISK
MEASUREMENT OF MACULAR PIGMENT OPTICAL DENSITY
PREVENTION-MACULAR RISK ASSESSMENT
NUTRITION/NUTRACEUTICAL PRESCRIBING
MONITORING- FUNDUS IMAGING, PHP, OCT, ELECTRODIAGNOSTIC TESTING
• DRY EYE-
IDENTIFYING THOSE AFFECTED AND SILENT SUFFERERS
NUTRITION/NUTRACEUTICAL PRESCRIBING
MONITORING CONDITION- TOPICAL MEDS, PUNCTAL PLUGS
• DIABETES-
IDENTIFYING THOSE AT RISK (7 MILLION UNDIAGNOSED)
PREVENTION-MACULAR MODEL WITH MACULAR EDEMA
NUTRITION/NUTRACEUTICAL PRESCRIBING
MONITORING- FUNDUS IMAGING, PHP, OCT, ELECTRODIAGNOSTIC TESTING
26
AMD-RISK FACTORS AMD LIFESTYLE RISKS
• Smokers-educating and recommending cessation strategies
• Obesity & Poor Diet-educating and recommending diet/exercise strategies
• Low Macular Pigment-educating and recommending measurement
SMOKING RISK
• Tobacco Effects-Toxins build up at the cellular level aging/oxidizing tissue at a greater rate
• Smoking Cessation-Hypnosis, oral medication, patch, cold turkey if possible
• Low Macular Pigment-educating and recommending measurement
OBESITY/POOR DIET RISK
OBESITY/POOR DIET RISK
• Diet-Foods rich in anti-oxidants are essential (plant based foods vs. processed and fatty meats
(SODA AWFUL CULPRIT)
• Exercise-educating on simple ways to implement moving/increasing heart rate
• Low Macular Pigment-educating and recommending measurement
27
LOW MACULAR PIGMENT RISKS
• “Internal Sunglass”-Less protection for macular aging/oxidation
• Macular Carotenoids-Lutein/Zeaxanthin
• Visual Performance-Decreases perception and clarity
• Reaction Time/Glare-Improves driving/night conditions
MPOD TESTING
• Any patient at risk should be educated and consider measurement
• Proactively identify during pre-testing
-Utilize questionnaire
-Pre-tester determination
• Complete testing where best in your patient flow
-End of entrance tests prior to doctor exam
-End of full exam per doctor recommendation
MPOD TESTING
• No CPT codes for wellness/preventive testing/Determine cost of test
• Determine if change of diet appropriate
• Determine if prescription for vitamin supplements appropriate
• Determine appropriate follow up
MPOD TESTING
• Low MPOD <0.25
• Mid-range MPOD 0.26-0.45
• High MPOD >0.46
DIET
• Every at risk patient (no matter what pigment level) should be educated on a healthy diet
1. Dark green leafy vegetables: spinach, kale, brussel sprouts, broccoli
2. Peppers of color: red, orange, yellow
3. Berries: darker the berry the better—blue/blackberries
4. Omega 3’s: Don’t just think fish! Healthy oils in almonds, walnuts, flaxseed
5. Indulgences: Red wine (pinot), dark chocolate (70% coco or greater)
SUPPLEMENT RECOMMENDATION
• Anyone with family Hx should be on AREDS 2 Formula
• Low Pigment-AREDS 2 Formula
• Smokers-Formula without Vitamin A
• Drusen/peripheral or central-AREDS 2 Formula or further testing???
• Macular Risk Assessment Recommendation-Targeted Tx
28
EYE PROMISE RESTORE
Same 2:1 ratio of Zeaxanthin & Lutein as center of a healthy macula.
Science-based eye supplements designed to be taken with a multi-vitamin.
Highest quality and quantity of dietary Zeaxanthin in a single dose (8mg).
Backed by more than 20 years of research and development.
Available only through Eye Care Professionals and Zeavision.
EYE PROMISE RESTORE
EYE PROMISE RESTORE• ZEAXANTHIN (8 MG)
• A SUPERIOR PHOTO-PROTECTANT AND ANTIOXIDANT DUE TO ITS CHEMICAL STRUCTURE. PRIMARILY FOUND IN THE
CENTRAL PART OF THE MACULA, LOW LEVELS ARE ASSOCIATED WITH INCREASED RISK OF AMD.
• LUTEIN (4 MG)
• PRIMARILY FOUND IN THE PERIPHERAL PART OF THE MACULA, AN IMPORTANT PHOTO-PROTECTANT THAT HELPS FILTER
DAMAGING BLUE LIGHT AS IT ENTER THE EYE.
• OMEGA-3 (190 MG, TOTAL FISH OIL, 250 MG)
• FATTY ACIDS FROM FISH ARE A VITAL AND SERIOUSLY LACKING NUTRIENT – SIGNIFICANT STRUCTURAL COMPONENTS
OF TISSUES’ CELL MEMBRANES THROUGHOUT THE BODY – ESPECIALLY RICH IN THE BRAIN AND PARTICULARLY
IMPORTANT IN THE RETINA WHERE DEFICIENCY CAN RESULT IN DECREASED VISION.
• CON’T…
EYE PROMISE RESTORE• VITAMIN C (120 MG)
• A MAJOR ANTIOXIDANT NUTRIENT – STRENGTHENS BLOOD VESSELS, AIDS IN IRON ABSORPTION, AND IS REQUIRED FOR THE SYNTHESIS OF COLLAGEN, THE INTERCELLULAR “CEMENT” WHICH HOLDS TISSUES TOGETHER. EXCELLENT HEALING AGENT THAT HELPS THE BODY RESIST INFECTION.
• VITAMIN D3 (1,000 IU)
• D3 MAINTAINS ADEQUATE LEVELS OF VITAMIN D IN THE BODY – REGULATE THE BODY’S INFLAMMATORY RESPONSE; IMMUNE HEALTH;JOINTS AND MUSCLES; AND MORE.
• VITAMIN E (60 IU)
• MAJOR ANTIOXIDANT THAT SLOWS CELLULAR AGING DUE TO OXIDATION, STRENGTHENS BLOOD VESSELS, AND MAY HELP COMBAT WET AMD.
• ZINC (15MG)
• VERY IMPORTANT IN HUMAN METABOLISM – MORE THAN 100 SPECIFIC ENZYMES REQUIRE ZINC FOR THEIR CATALYTIC FUNCTION. RECOMMENDED UPPER TOLERABLE LEVEL OF ZINC IS 40 MG PER DAY.
• MIXED TOCOPHEROLS (6 MG)
• PLAY A SIGNIFICANT ROLE IN SYSTEMIC INFLAMMATORY ADJUSTMENTS.
• ALPHA LIPOIC ACID (10 MG)
• A POWERFUL ANTIOXIDANT THAT WORKS MOST EFFECTIVELY IN SYNERGY WITH VITAMINS C & E – FIGHTING FREE RADICALS THAT CAN DAMAGE CELL STRUCTURES, IMPAIR THE IMMUNE SYSTEM, AND MAY CONTRIBUTE TO VISION LOSS.
FOLLOW-UP RECOMMENDATION(NO RETINAL FINDINGS)
• Any diet/supplement prescribed should mandate a 6 month follow up
• F/U visit requires treatment plan
• After nutrition/nutraceutical clinical balance found yearly monitoring important
29
RETINAL FINDINGS INCREASING RISKS
• Peripheral drusen
• Macular changes
• Diagnosed AMD
MACULAR RISK ASSESSMENT TEST
• Genetic testing results to determine maximum preventive treatment plan:
1. 2,5 &10 year risk
2. Lifetime risk
3. Targeting nutraceuticals
• Lab directly bills Medicare patients and any insured patient with only a $50 co-pay
• Vita Risk is NOT billable to insurance and costs $500.00
MACULA RISK® - VITA RISK®
AMD GENETIC TESTING&
AREDS PHARMACOGENETICS
CODES FOR GENETIC TESTING
362.50-NON-SPECIFIC AMD
362.51-NON-EXUDATIVE AMD
362.52-EXUDATIVE AMD
362.57-DRUSEN
OFFICE LOCATIONS
Toronto, Canada
Grand Rapids, MI
INCIDENCE OF AMD IS INCREASING
- > 2 million new cases per year in USA
- Overt 30 million in USA have AMD (AREDS 2, 3 and 4)
- More than 7 million have intermediate AMD
- 10,000 boomers turn 65 every day in North America
- 550 new cases of CNV every day in USA
30
MACULA RISK & VITA RISK
Carl C. Awh, Anne‐Marie Lane, Steven Hawken, Brent Zanke, Ivana K. Kim
Ophthalmology – November 2013
Macula Risk®2, 5, 10‐year Prognostic
Vita Risk™AREDS Pharmacogenetic
+
Who Will Lose Vision Which Eye Supplement
CFH
CFI CFBC2C3
ARMS2
TIMP3 COL8A1
LIPC APOECETP ABCA1 CFH
CFICFBC2C3
ARMS2
TIMP3COL8A1
LIPCAPOE
MACULA RISK GENES
Complement
Oxygen Metabolism
Extracellular Matrix
Cholesterol Metabolism
MACULA RISK - PROGNOSTIC VALIDATION - 2012 IOVS
PROSPECTIVE ASSESSMENT OF GENETIC EFFECTS ON PROGRESSION TO DIFFERENT STAGES OF AGE-RELATED MACULAR
DEGENERATION USING MULTISTATE MARKOV MODELS
YI YU, ROBYN REYNOLDS, BERNARD ROSNER, MARK J. DALY, AND JOHANNA M. SEDDON
INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE, MARCH 2012, VOL. 53, NO. 3
2560 CAUCASIANSAVERAGE FOLLOW UP = 10.3 YEARS
5 YEAR PREDICTIVE POWER = 0.883 ‘C’ STATISTIC SCORE
10 YEAR PREDICTIVE POWER = 0.895 ‘C’ STATISTIC SCORE
MACULA RISK - PROGNOSTIC VALIDATION - 2013 JAMA
VALIDATION OF A PREDICTION ALGORITHM FOR PROGRESSION TO ADVANCED AMD
JOHANNA SEDDON, ROBYN REYNOLDS, YI YU, BERNARD ROSNER
JAMA OPHTHALMOLOGY, VOLUME 131 (NO. 4), APRIL 2013
980 CAUCASIANSAVERAGE FOLLOW UP = 10.3 YEARS
PREDICTION MODEL INCLUDING 5 GENES, AMD STATUS AND DEMOGRAPHIC VARIABLES
10 YEAR PREDICTIVE POWER = 0.81
SENSITIVITY AND SPECIFICITY >80%
COMBINING CLINICAL EXAM AND GENETICS
CNV Cases = 2,105 EyesAverage Visual
Acuity at Presentation
Without Genetic Analysis 20/145
With Genetic Analysis 20/77
Macula Risk improves Outcomes
American Society of Retina SpecialistsAnnual Meeting – August 2013
Peter Sonkin MD, Tennessee Retina
31
MACULA RISK PATIENT REPORT
Gene SNP Result Risk
ABCA1 rs1883025 TT —
APOE rs7412 CC —
APOE rs429358 TT —
ARMS2 372_815del443in ND *C2 rs9332739 GG **C3 rs2230199 CC —
CETP rs3764261 AC *CFB rs541862 AA **CFH rs412852 CT —
CFH rs3766405 CC —
CFH rs1048663 AG —
CFI rs10033900 TT **COL8A1 rs13095226 TT **LIPC rs10468017 CT *TIMP3 rs9621532 AA **
Genetic Risk Percentile: 29% (range: 0 - 100, average = 50)
Signed by Robert Carlson, MD
Signed on October 31, 2014
Accession Number: AMLPGX-00000
Patient Name: John Doe
Patient Name: John Doe DOB: DD-MM-YY Gender: M
Accession: AMLPGX-00000 Specimen Type: Buccal Sample Age: 74
Collection Date: October 09, 2014
Receipt Date: October 20, 2014
Report Date: October 31, 2014
Physician Name:
Receiving Facility:
Facility Address:
Progression Risk to CNV or GA 2-Year 5-Year 10-Year
Patient: Doe, John (74.0) 7% 24% 48%
10-Year Macula Risk Score: MR4
MR
5
4
3
2
1
90
60
30
10
5
0
PR
OG
RE
SS
ION
RIS
K (
%)
TIME (Years)
1 2 3 4 5 6 7 8 9 10
10-Year Macula Risk Score For Progression to CNV or GA
AREDS without Zinc
Vitamin Recommendation based on CFH and ARMS2 genotyping
Non Genetic FeaturesRISK PARAMETER VALUE
AMD Status OD Intermediate
AMD Status OS Early
Smoking Smoker
Education High School or Greater
Height 5 ft 10.0 in
Weight 180 lbs
BMI 26
Genetic Features
— Low * Med ** High
801 Broadway NW Grand Rapids MI 49504
Phone: 866.964.5182 Fax: 866.964.5184
Macula Risk®Report
PRIMARY EYE CARE PROTOCOL
Recommended practice protocol developed by the Macula Risk Optometry Advisory Board: L. Alexander, D. Cunningham, M. Dunbar,S. Ferrucci, J. Gerson, P. Karpecki, G. Morgan, D. Nelson, J. Rumpakis, J. Schaeffer, L. Semes, D. Shechtman, J. Sherman, K. Smick
MACULA RISK & VITA RISK
Carl C. Awh, Anne‐Marie Lane, Steven Hawken, Brent Zanke, Ivana K. Kim
Ophthalmology – November 2013
Macula Risk®2, 5, 10‐year Prognostic
Vita Risk™AREDS Pharmacogenetic
+
Who Will Lose Vision Which Eye Supplement
AMD TREATMENT - STANDARD OF CARE
Dry AMD
AREDS 2 Ocular Vitamins
Vitamin E (400 IU), Vitamin C (500mg), Lutein (10 mg), Zeaxanthin (2 mg), Copper (2 mg), Zinc (80mg/25mg)
Wet AMD
VEGF INHIBITOR INJECTIONS•AVASTIN (bevacizumab)•LUCENTIS (ranibizumab)•EYLEA (aflibercept)•Steroids, Visudyne, Macugen…
Standard of Care
Standard of Care
Genetic Testing for Supplements – WHY?
Genetic Variation Determines Treatment
PERSONALIZED MEDICINE
AREDS for all AMD patients
Varied Response to Treatment
32
TAKE HOME MESSAGE (15%)
Pat ient s wit h 2 CFH r isk alleles and 0 ARMS2 r isk alleles should not
take t he AREDS for mulat ion.
2005: Immunocytochemistry of a druse (D) - eye of an 85-year-old donor.
Bok D PNAS 2005;102:7053-7054
©2005 by National Academy of Sciences
IMRE LENGYEL , JANE M. FLINN, TU ̈NDE PETT, DAVID H. LINKOUS, KATHERINE CANO, ALAN C. BIRD, ANTONIO LANZIROTTI, CHRISTOPHER J. FREDERICKSON, FREDERIK J.G.M. VAN KUIJK
Complement cascade proteins and zinc found in drusen are considered evidence of local inflammation in the pathogenesis of AMD.
CFH binds zinc, which can neutralize its ability to inhibit complement component C3b.
Experimental Eye Research 84 (2007) 772‐780
AREDS Varied response to CFH genetic risk
AREDS AND CFH GENETIC RISK - 2009
“SIGNIFICANT INTERACTION BETWEEN THE NUMBER OF RISK ALLELES FOR THE CFH Y402H VARIANT AND TREATMENT, WHEREBY PATIENTS WITH THE CC (I.E., HIGH RISK) GENOTYPE WERE LESS LIKELY TO BENEFIT FROM THE ANTIOXIDANT–MINERAL SUPPLEMENTATION THAN SUBJECTS WITH THE TT AND CT GENOTYPES.”
SEDDON JM, REYNOLDS R, MALLER J, FAGERNESS JA, DALY M, ROSNER B.PREDICTION MODEL FOR PREVALENCE AND INCIDENCE OF ADVANCED AGE-RELATED MACULAR DEGENERATION BASED ON GENETIC, DEMOGRAPHIC AND ENVIRONMENTAL VARIABLES. IOVS 2009;50(5):2044-2053
Why CFH Risk is pro‐inflammatory
Increase Zinc
1. CFH binds C3 and CRP2. High Risk CFH does not bind
C3 well3. Increased Zinc lowers CRP
Am J Clin Nutr; 2010;91:1634‐41
CRP
33
S
• FOR 23% OF PATIENTS, THE AREDS FORMULATION WAS THE BEST TREATMENT
• 49% OF PATIENTS DERIVE MORE BENEFIT FROM A FORMULATION OTHER THAN AREDS.
• FOR 13% OF THE PATIENTS THE AREDS COMBINATION WAS HARMFUL AND ACCELERATED VISION LOSS SIGNIFICANTLY FASTER THAN PLACEBO;
AWH C, KIM I ET AL NOVEMBER 2013
CFH RISK GENES
ARMS2 RISK GENES
0 1 2
012
CFH Zinc increases progression risk
Antioxidants increase progression risk
ZincZinc + AO
Placebo
AO ( Vit C & E)
Placebo and AREDS
Projected Results
ARMS2
ADVANCED OCULAR CARE (MAY 2014)
NEI – DISPUTES INTERACTION
1. AREDS – Awh Projects 75% of C2A0 will have progressed at 12 years2. AREDS2 – No report on genetic findings3. Editors Request Awh to reconcile results
AREDS - CFH High Risk and ARMS2 Low Risk
34
OPHTHALMOLOGY – SEPT 2014
1. 989 patients – 131 w Zinc anomaly – High CFH Risk2. High–risk ARMS2 benefit from Zinc3. Reconciled Chew Analyses
HIGH CFH RISK – LOW ARMS2
LOW CFH RISK – HIGH ARMS2 LETTER TO THE EDITOR FEB 2015CARL AWH MD
CONTRARY TO THE CONCLUSION ADVANCED BY CHEW ET AL., THEIR DATA POWERFULLYDEMONSTRATES THAT THE BENEFITS OF ZINC OR THE AREDS FORMULATION ACCRUE ALMOSTEXCLUSIVELY TO THOSE WITH LOW CFH/HIGH ARMS2 GENETIC RISK, COUNTERED BY A DELETERIOUSEFFECT FOR THOSE WITH HIGH CFH/LOW ARMS2 RISK. THIS COULD EXPLAIN THE LACK OF OVERALLEFFICACY OF THE AREDS FORMULATION IN THIS GROUP OF 1237 PATIENTS, REPRESENTING ALMOSTHALF OF THE 2516 PATIENTS IN THE SUBGROUP ANALYSIS UPON WHICH THE AREDS TREATMENTRECOMMENDATIONS WERE BASED.
AREDS REPORT 38 IS AN INDEPENDENT SOURCE OF GENOTYPING AND OUTCOMES DATA WHICHPROVIDES FURTHER EVIDENCE THAT GENETIC TESTING MAY IDENTIFY PATIENTS WHO ARE MOSTLIKELY TO BENEFIT FROM THE AREDS FORMULATION, AS WELL AS THOSE (WITH HIGH CFH AND LOWARMS2 RISK) WHO SHOULD AVOID HIGH-DOSE ZINC, ALONE OR AS A COMPONENT OF THE AREDSFORMULATION, UNTIL THOSE WHO PROMOTE ITS USE PROVE IT TO BE BOTH SAFE AND EFFECTIVE
FOR THIS GROUP OF PATIENTS.
ARMS2 RISK IMPAIRS O2 METABOLISM IN RPE
Superoxide Dismutase 2 (SOD2) function may be impaired in the presence of ARMS2 risk alleles, leading to increased oxidative damage in RPE cells.
35
ZINC CATALYSES SOD1 AMELIORATES ARMS2 RISK
ARMS2 localizes to mitochondria, potentially affecting the interaction of antioxidants and free radicals.
Zinc activates SOD1
inCytoplasm
ARMS2 INACTIVATIO
NOf SOD2
Superoxide Dismutase (1 &2) catalyze Oxygen Metabolism in the RPE
1. High Risk ARMS2 Deactivates SOD2 in mitochondria in the RPE2. Zinc activates SOD1 in Cytoplasm to support Oxygen Metabolism
VITA RISK PATIENT REPORT Genotype Directed Eye Vitamin Formulations
10 Manufacturers of AREDS Formulations for Macula Risk
www.macularisk.com
In your Practice
1. Check for Vitamins2. Check for AMD3. Swab for the Genetic Test4. Rx the best Eye Supplements5. Increased surveillance for
High Risk Patients
GETTING STARTED
209
RECOMMENDATION - PERSONALIZED MEDICINE
36
SUMMARY
MACULA RISK TESTING IMPROVES PATIENT OUTCOMES
IN AMD
– AMD PROGNOSIS
– AREDS SUPPLEMENTS
PERSONALIZED MEDICINE
EYE PROMISE RESTORE ZINC FREE
FOLLOW-UP RECOMMENDATIONRETINAL FINDINGS
• Retinal findings increase risk and need for prevention with vitamin recommendation
• Retinal findings need greater monitoring of structure and function
• Structure: Fundus imaging, Auto-fluorescence, OCT
• Function: Preferential Hyperacuity Perimetry (PHP), Microperimetry, pERG, dark adaptation
CODING/BILLING STRUCTURE/FUNCTION
• FUNDUS IMAGING/AUTO-FLUORESCENCE-92250 -$83.04
• OCT-92132,92133,92134 -$44.76-$45.88
• PHP-92083 -$69.13
• MICROPERIMETRY-92083 -$69.13
• PERG-92275 -$168.59
• DARK ADAPTATION-92284 -$64.80
DRY EYE MANAGEMENT
• MUCH OF DRY EYE IS ENVIRONMENTAL/LIFESTYLE.
• BABY BOOMER’S ARE MOST IN NEED…MEN-BLEPH/MEIBOMIAN…WOMEN-DRYNESS
• DON’T FORGET ABOUT THE SILENT SUFFERERS/CL WEARERS.
• PCP’S AND INTERNISTS NOT HAVING THE DISCUSSION ABOUT NUTRITION!!!!
DRY EYE MANAGEMENT-TRADITIONAL
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DRY EYE MANAGEMENT-LIFESTYLE
• ENVIRONMENT-FORCE AIR/HEAT, HUMIDITY LEVELS, ALLERGANS, DANDER
• WATER INTAKE-HYDRATION DAILY
• CAFFEINE INTAKE-UP TO TWO SERVINGS GOOD…MORE BAD
• MAKE UP/CREAMS-POTENTIAL FOR MEIBOMIAN DYSFUNCTION
• CHRONIC BLEPH/MEIBOMIANITIS/ROSACEA-MEDICAL CONDITIONS
DRY EYE MANAGEMENT-SUPPLEMENTS
EZ TEARS SCIENTIFIC BENEFITS• OMEGA-3 (1,145 MG, EPA/DHA = 590MG/440 MG)
FATTY ACIDS FROM FISH ARE VITAL AND LACKING IN THE TYPICAL DIET; SIGNIFICANT
STRUCTURAL COMPONENTS OF TISSUE CELL MEMBRANES THROUGHOUT THE BODY; DHA IS RICH IN THE BRAIN AND RETINA WHERE DEFICIENCY CAN RESULT IN DECREASED VISION.
• VITAMIN A (AS RETINYL PALMITATE 1,000 IU)
FAT SOLUBLE VITAMIN (ABSORBED BY THE BODY WITH THE HELP OF FATS) FOR CORNEAL SURFACE HEALTH; MUCOSAL, CONJUNCTIVAL, MEIBOMIAN AND LACRIMAL GLAND HEALTH; MAJOR IMPORTANCE IN THE MUCOUS LAYER OF TEAR PRODUCTION.
• VITAMIN D3 (2,000 IU)
FAT SOLUBLE VITAMIN DEFICIENT IN THE AMERICAN DIET; POSITIVE EFFECT ON IMMUNITY AND SYSTEMIC INFLAMMATION, IMMUNE HEALTH, JOINTS AND MUSCLES, AND MORE.
EZ TEARS SCIENTIFIC BENEFITS• VITAMIN E (D-ALPHA TOCOPHEROL 60 IU)
• FAT SOLUBLE VITAMINS AND RELATED COMPOUNDS ESSENTIAL FOR REDUCTION OF SYSTEMIC AND OCULAR INFLAMMATION; THESE COMPOUNDS ARE FOUND IN A HEALTHY DIET AND IMPORTANT IN STABILIZING OMEGA-3 FATTY ACID FORMULAS.
• EVENING PRIMROSE OIL (100 MG)• CONTAINS GLA (GAMMA-LINOLEIC ACID) – SHOWN TO FAVORABLY AFFECT DRY EYE SYMPTOMS BY INHIBITING
CONVERSION OF OMEGA-6 FATTY ACIDS TO PRO-INFLAMMATORY MOLECULES.
• TURMERIC EXTRACT (50 MG)• INCLUDES CURCUMIN WITH SYSTEMIC AND OCULAR ANTI-INFLAMMATORY PROPERTIES; INHIBITS CONVERSION
OF OMEGA-6 FATTY ACIDS TO PRO-INFLAMMATORY PROSTAGLANDINS AND INHIBITION OF OTHER PRO-INFLAMMATORY SIGNALS ON THE OCULAR SURFACE.
• GREEN TEA EXTRACT (50 MG)• PROVIDES ANTIOXIDANT EFFECTS IN SYSTEMIC AND OCULAR TISSUES, REDUCING THE EFFECT OF
INFLAMMATORY COMPOUNDS THAT ARE A MAJOR CAUSE OF DRY EYE.
• MIXED TOCOTRIENOL/MIXED TOCOPHEROL (20 MG)• PLAYS A SIGNIFICANT ROLE IN REDUCING SYSTEMIC INFLAMMATION.
EZ TEARS PATIENT BENEFITS
• SAVED MANY PATIENTS FROM CL DROPOUT…BENEFITS IN AS SOON AS 2 WEEKS
• MONEY BACK 30 DAY GUARANTEE
• ADDED BENEFITS OF OMEGA 3…HEART, JOINTS, BRAIN
• LOVE THE D3 BENEFITS!!!!!
FOLLOW-UP RECOMMENDATION
• START 2 EZ TEAR TABS PO QD
• USE IN CONJUNCTION WITH OTHER TX…DAILY DISPOSABLES, BLEPH/MEIBOMIAN TX, PLUGS,
TOPICAL (SX’S GREATLY REDUCED SO NEED FOR ADJUNCT TX IS LESS)
• SEE IN 2-4 WEEKS FOR PROGRESS…IF HIGH RISK FOR MACULAR DISEASE CAN USE WITH
ZEAXANTHIN AND/OR ZEA/LUTEIN COMBO TX
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OTHER OMEGA 3 SUPPLEMENTS AVAILABLE
• THERATEARS NUTRITION-1200MG O3’S (450MG EPA, 300 DHA, 450MG ALA), VITAMIN E, 3
CAPSULES
• NORDIC NATURALS ULTIMATE-1280MG O3’S (650MG EPA, 450 DHA, 180 OTHER) 2 CAPSULES
** CONTINUE TO LOOK AT STUDIES AND SCIENCE BEHIND PRODUCTS!
DIABETIC/MACULAR MANAGEMENT
• DON’T FORGET ABOUT THE GREATER RISK FOR MACULAR DISEASE!!!
• NEW RESEARCH IN RECOMMENDING NUTRITIONAL SUPPLEMENTS FOR DIABETICS
• PCP’S AND INTERNISTS NOT HAVING THE DISCUSSION!!!!
DIABETIC/RETINAL MANAGEMENT
• DVS FORMULA TO REDUCE RISK OF VASCULAR CHANGES
• Support retinal metabolism, structure, and function
• Promote blood vessel health• Combat oxidative stress• Increase Macular Pigment Optical Density
(MPOD)• Improved visual performance
MAINTAIN HEALTHY BLOOD VESSELS
• ALPHA LIPOIC ACID – POTENT MITOCHONDRIAL ANTIOXIDANT THAT TARGETS HARMFUL
PROTEINS*
• GRAPESEED EXTRACT & RESVERATROL – REDUCES OXIDATIVE STRESS, ENDOTHELIAL
DYSFUNCTION AND APOPTOSIS*
• COQ10- IMPROVES ENDOTHELIAL CELL FUNCTION AND MAY HELP WITH LIPID PEROXIDATION*
• VITAMIN D – LOW SERUM VITAMIN D IS ASSOCIATED WITH A HOST OF PHYSIOLOGIC
CHALLENGES*
• VITAMINS C & E (AND TOCOTRIENOLS) – HELP REDUCE OXIDATIVE STRESS AND IMPROVE
ENDOTHELIAL FUNCTION*
• GREEN TEA LEAF – HELPS IN REDUCTION OF VASCULAR ENDOTHELIAL GROWTH FACTOR
(VEGF)*
MAINTAIN HEALTHY BLOOD VESSELS
• BENFOTIAMINE – AIDS IN SUPPORT OF BIOCHEMICAL PATHWAYS ASSOCIATED WITH
VASCULAR HEALTH*
• PYCNOGENOL® – HELPS IMPROVE RETINAL CAPILLARY INTEGRITY, AND IMPROVED RETINAL
BLOOD FLOW*
• CURCUMIN – DEMONSTRATES THE ABILITY TO IMPROVE THE STATUS OF ANGIOGENIC
SIGNALING PROTEINS*
• FISH OIL (DHA & EPA) – IMPROVES CELL MEMBRANE INTEGRITY AND VASCULAR PERMEABILITY*
• ZEAXANTHIN – REDUCES OXIDATIVE STRESS, AND HELPS PROTECT VISUAL CELLS (CONE
PROTECTION)*
• LUTEIN – REDUCES OXIDATIVE STRESS, AND HELPS PROTECT VISUAL CELLS (ROD
PROTECTION)*
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MACULAR MANAGEMENT
NO RETINAL FINDINGS
• ASSESS RISK FACTORS: Age, Gender, Family
Hx, Diabetic, Cardiovascular Disease,
Smoking, Obesity/Poor Diet
• Run MPOD
• Prescribe lifestyle and diet changes
• Prescribe nutritional supplements
RETINAL FINDINGS
• Offer MPOD to monitor progress
• Offer Macular Risk Assessment
• Target nutritional supplement Rx’d
• Monitor Function: PHP, microperimetry, pERG,
AdaptDx (ONLY OBJECTIVE TEST IS pERG)
• Monitor Structure: Digital imaging, OCT, auto-
fluorescence
DIABETIC MANAGEMENT
NO RETINAL FINDINGS
• ASSESS RISK FACTORS: Age, Gender, Family
Hx, HgA1C, Cardiovascular Disease, Smoking,
Obesity/Poor Diet
• Run MPOD
• Prescribe lifestyle and diet changes
• Prescribe DVS supplement
• SEE YEARLY (SOONER c Sx’s)
RETINAL MACULAR FINDINGS
• Offer MPOD to monitor progress
• Offer Macular Risk Assessment
• Target nutritional supplement Rx’d
• Monitor Function: PHP, microperimetry, pERG
• Monitor Structure: Digital imaging, OCT, auto-
fluorescence
• SEE PRN WITH CLINICAL PRESENTATION
OUR COMMITMENT AS DOCS KEEPING THE FAITH AND KEEPING IT FUN!!
• OUR RESPONSIBILITY TO DIFFERENTIATE
• OUR DEDICATION TO PROMOTING/LEADING THE MEDICAL MODEL
• OUR RESPONSIBILITY TO DEVELOPING ACO RELATIONSHIPS
OUR COMMITMENT TO OUR PATIENTS/PRACTICE
• GREAT PATIENT MANAGEMENT IS THE HEALTHIEST PRACTICE MANAGEMENT
HAVE FUN AGAIN!!